Lipitor 10 mg film-coated tablets *
Pharmacy Only: Prescription

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 20 September 2021

File name

DEC202112235-V_Reg SPC LR 31_1 10mg IE - clean_1632146201.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Correction of spelling/typing errors

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 20 September 2021

File name

DEC202112235-V_Reg PIL LR 35_1 IE - clean_1632146125.pdf

Reasons for updating

  • Correction of spelling/typing errors

Updated on 31 March 2021

File name

DEC202104589-V_Reg SPC LR 30_1 10mg IE-clean_1617185983.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.1 - List of excipients

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 31 March 2021

File name

DEC202104589-V_Reg PIL LR 34_0 IE-clean_1617185908.pdf

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - excipient warnings
  • Change to section 4 - how to report a side effect
  • Change to section 6 - what the product contains

Updated on 06 October 2020

File name

Reg PIL LR 32_0 IE Clean_1601978304.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - marketing authorisation holder

Updated on 19 November 2019

File name

DEC201964482_Reg PIL LR 31_1 IE - Clean_1574176179.pdf

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 19 November 2019

File name

DEC201964482_Reg SPC LR 29_1 10mg IE - Clean_1574176082.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 31 July 2019

File name

DEC201939369_Reg PIL LR 30_2 IE _1564571497.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 31 July 2019

File name

DEC201939369_Reg SPC LR 28_2 10mg IE_1564571531.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

SmPC: Updated as follows:

 Section 4.8- updated to include “Muscle rapture” under rare side effects on PRAC recommendation (All strengths).

Updated on 13 May 2019

File name

DEC201924154_Reg PIL LR 29_1 IE - Clean_1557733040.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 13 May 2019

File name

DEC201924154_Reg SPC LR 27_1 10mg IE - Clean_1557733892.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows: Sections 4.8, 10 has been updated as per the CMDh endorsed PRAC recommendation to include lupus related events.

Updated on 11 January 2019

File name

Reg PIL LR 28_1 IE - Clean_1547219342.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 11 January 2019

File name

Reg SPC LR 26_1 10mg IE- Clean_1547219419.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

The following changes to the labelling have been approved.  Please refer to attached copy/copies of labelling documentation for full details.

The SPC has been updated as follows: Sections 4.2, 4.3, 4.4, 4.5, 5.1, 5.2 Change in line with PRAC recommendations (drug drug interactions of atorvastatin with HCV protease inhibitor combinations elbasvir/grazoprevir and glecaprevir/pibrentasvir) and section 4.8 ADR reporting

The PIL has been updated to reflect the SPC changes. See PIL tick list for sections updated.

Updated on 28 November 2018

File name

Reg SPC LR 25_1 10mg IE_1543400253.pdf

Reasons for updating

  • Improved presentation of SPC

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Improved presentation of SPC uploaded

Updated on 30 August 2018

File name

Reg_SPC_LR_25_1_10mg_IE_clean_1535636086.pdf

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 5.1 - Pharmacodynamic properties

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

Section 4.5: a correction to the drug interaction study duration for atorvastatin with colestipol presented in ‘Table 1: Effect of co-administered medicinal products on the pharmacokinetics of atorvastatin’.

Section 5.1: an editorial update to the footnote for Table 3

Updated on 05 June 2018

File name

Reg_SPC_LR_25_1_10mg_IE_clean.docx

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 5.1 - Pharmacodynamic properties

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

Section 4.5: a correction to the drug interaction study duration for atorvastatin with colestipol presented in ‘Table 1: Effect of co-administered medicinal products on the pharmacokinetics of atorvastatin’.

Section 5.1: an editorial update to the footnote for Table 3

Updated on 17 February 2017

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 17 February 2017

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

Sections 1, 2, 3, 4.6, 5.2, 5.3, 6.4, 6.6 – administrative update

Section 4.2, 4.8, 5.1 - paediatric data update

Section 4.4 – paediatric data update,  CMDh wording for fusidic acid interaction

Section 4.5 - CMDh wording for fusidic acid interaction, harmonised presentation of the drug interaction data

Updated on 16 February 2017

File name

PIL_8757_784.pdf

Reasons for updating

  • New PIL for new product

Updated on 16 February 2017

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 3 - dose and frequency
  • Change to section 3 - use in children/adolescents
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
  • Correction of spelling/typing errors

Updated on 04 January 2016

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.1 - List of excipients
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

updates to sections:

2, 3, 4.2, 4.3, 4.4, 4.5, 4.8, 5.2, 6.1. 9 and 10 - to bring in line with QRD template

Updated on 22 December 2015

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to storage instructions
  • Change to side-effects
  • Change to further information section
  • Change to date of revision
  • Change to appearance of the medicine
  • Change to name of manufacturer

Updated on 08 April 2015

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows

Section 4.4: Special warnings and precautions for use

Sub-heading: Concomitant treatment with other medicinal products

Update to wording on ‘immune-mediated necrotizing myopathy (IMNM)’ to bring it in line with the PRAC wording.

Section 4.8. Undesirable effects

Sub-heading: Musculoskeletal and connective tissue disorders

Addition of reference to section 4.4.

Updated on 30 March 2015

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision

Updated on 29 May 2014

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Update to sections 4.4, 4.5 & 4.8

Updated on 20 May 2014

Reasons for updating

  • Change to side-effects
  • Change to drug interactions
  • Change to date of revision

Updated on 07 November 2013

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Improved electronic presentation

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Changes to sections 4.4, 4.5, 4.8

Updated on 01 November 2013

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to storage instructions
  • Change to side-effects
  • Change to drug interactions
  • Change to date of revision
  • Change to improve clarity and readability

Updated on 05 July 2012

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

SPC (update to section 4.4 & 4.8 with wording on statins and diabetes)

Updated on 02 July 2012

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision

Updated on 11 January 2012

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

SmPC update to section 7, 8 and 10.

Updated on 09 January 2012

Reasons for updating

  • Change to MA holder contact details

Updated on 03 January 2012

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

SPC update to section 6.5

Updated on 21 December 2011

Reasons for updating

  • Introduction of new pack/pack size

Updated on 02 September 2011

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Update to section 6.5

Updated on 31 August 2011

Reasons for updating

  • Introduction of new pack/pack size

Updated on 10 May 2011

Reasons for updating

  • Correction of spelling/typing errors

Updated on 10 May 2011

Reasons for updating

  • Correction of spelling/typing errors

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Correction of typo

Updated on 21 March 2011

Reasons for updating

  • Change due to harmonisation of PIL

Updated on 10 March 2011

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4 - Clinical particulars
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5 - Pharmacological properties
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 5.4 - Radiation dosimetry
  • Change to section 6 - Pharmaceutical particulars
  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

The SmPC has been updated to harmonise the text according to the article 30 referral. This has resulted in a rewrite of the full SPC. As part of the module 3 harmonisation we have switched from the heritage oval tablets to the small round tablets

Updated on 19 October 2010

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company


SmPC Sections 4.1, 4.2, 4.4, 4.5, 4.8, 5.1, 5.2 and 10 have changed

Updated on 15 October 2010

Reasons for updating

  • Change to, or new use for medicine
  • Change to side-effects
  • Change to date of revision
  • Change to dosage and administration

Updated on 04 June 2010

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Changes to warnings and precautions, side effects and a correction to a typo in section 4.5.

Updated on 01 June 2010

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects

Updated on 13 May 2010

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects

Updated on 19 April 2010

Reasons for updating

  • Change to section 6.1 - List of excipients

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

  1. 
  2. Section 6.1 list of excipients has been updated to reflect the change

    Updated on 08 April 2010

    Reasons for updating

    • Change of inactive ingredient

    Updated on 04 January 2010

    Reasons for updating

    • Change of manufacturer

    Updated on 10 September 2009

    Reasons for updating

    • Change due to user-testing of patient information

    Updated on 23 January 2009

    Reasons for updating

    • Improved electronic presentation

    Legal category:Product subject to medical prescription which may be renewed (B)

    Updated on 06 January 2009

    Reasons for updating

    • Improved electronic presentation

    Legal category:Product subject to medical prescription which may be renewed (B)

    Updated on 22 December 2008

    Reasons for updating

    • Change to drug interactions

    Updated on 19 December 2008

    Reasons for updating

    • Change to section 4.4 - Special warnings and precautions for use
    • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

    Legal category:Product subject to medical prescription which may be renewed (B)

    Free text change information supplied by the pharmaceutical company

    4.4.            Special warnings and special precautions for use

    Temporary suspension of atorvastatin may be appropriate during fusidic acid therapy (see Section 4.5)

     

    4.5.            Interactions with other medicinal products and other forms of interaction

     

    Erythromycin, clarithromycin: Erythromycin and clarithromycin are known.At atorvastatin doses exceeding 40mg, clinical monitoring, including CPK measurement, of these patients is recommended. If these levels are significantly elevated (>5 times ULN), treatment with atorvastatin should be stopped (see Section 4.4), until the clarithromycin treatment course is completed and CPK has returned to baseline values.

     

    Itraconazole: Concomitant administration At atorvastatin doses exceeding 40 mg, clinical monitoring including CPK measurement, of these patients is recommended. If these levels are significantly elevated (>5 times ULN), treatment with atorvastatin should be stopped (see Section 4.4), until the itraconazole treatment course is completed and CPK has returned to baseline values.

     

    Fusidic Acid: Although interaction studies with atorvastatin and fusidic acid have not been conducted, severe muscle problems such as rhabdomyolysis have been reported in post-marketing experience with this combination. Patients should be closely monitored, including measurement of serum creatine phosphokinase (CPK) and temporary suspension of atorvastatin treatment may be appropriate.

    Updated on 21 August 2008

    Reasons for updating

    • Change to section 1 - Name of medicinal product

    Legal category:Product subject to medical prescription which may be renewed (B)

    Free text change information supplied by the pharmaceutical company

    Section1: The name of the product has been updated to include the pharmaceutical form.

    Updated on 21 August 2008

    Reasons for updating

    • Change of trade or active ingredient name
    • Change to date of revision

    Updated on 18 December 2007

    Reasons for updating

    • Change to warnings or special precautions for use
    • Change to side-effects
    • Change to drug interactions
    • Change to date of revision

    Updated on 18 December 2007

    Reasons for updating

    • Change to section 4.4 - Special warnings and precautions for use
    • Change to section 5.1 - Pharmacodynamic properties
    • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
    • Change to section 4.8 - Undesirable effects

    Legal category:Product subject to medical prescription which may be renewed (B)

    Free text change information supplied by the pharmaceutical company

    Section 4.4 and 5.1 – additional of SPARCL data and information

    Section 4.4 and 4.5 – inclusion of information about drug-drug interactions with atorvastatin

    Section 4.8 – Update Adverse Drug Reaction information after the completion of the MRP renewal

    Updated on 24 January 2007

    Reasons for updating

    • Change to, or new use for medicine

    Updated on 16 January 2007

    Reasons for updating

    • Change to section 4.1 - Therapeutic indications
    • Change to section 4.2 - Posology and method of administration
    • Change to section 5.1 - Pharmacodynamic properties

    Legal category:Product subject to medical prescription which may be renewed (B)

    Free text change information supplied by the pharmaceutical company

     Sections:

    4.1       - update to existing primary prevention indication

    4.2       - addition of dosing information relating to primary prevention studies

    5.1       - addition of CARDS primary prevention study description

                - modification of existing ASCOT study description wording

                - addition of MIRACL acute coronary syndrome study description

    Updated on 31 October 2006

    Reasons for updating

    • Change to section 4.2 - Posology and method of administration

    Legal category:Product subject to medical prescription which may be renewed (B)

    Free text change information supplied by the pharmaceutical company

     

    Update to section 4.2 of the SmPC for Lipitor Tablets (all strengths) to include the paediatric dosing information below:

     Paediatric use
     
    Paediatric use should only be carried out by specialists.  Experience in paediatrics is limited to a small number of  patients (age 4 - 17 years) with severe dyslipidaemias, such as homozygous familial hypercholesterolaemia. The recommended starting dose in this population is 10 mg of atorvastatin per day. The dose may be increased to 80 mg daily, according to the response and tolerability. Developmental safety data in this population have not been evaluated

    Updated on 01 September 2006

    Reasons for updating

    • Improved electronic presentation

    Updated on 14 August 2006

    Reasons for updating

    • Change to section 2 - Qualitative and quantitative composition
    • Change to section 6.4 - Special precautions for storage
    • Change to section 4.4 - Special warnings and precautions for use
    • Change to section 4.8 - Undesirable effects
    • Change to section 4.1 - Therapeutic indications
    • Change to section 4.2 - Posology and method of administration
    • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
    • Change to section 4.6 - Pregnancy and lactation

    Legal category:Product subject to medical prescription which may be renewed (B)

    Free text change information supplied by the pharmaceutical company

    Reason for Submission: Change to section 2 - qualitative and quantitative composition, Change to section 6. 4 - Special Precautions for Storage, Change to section 4.4 - Special Warnings and Precautions for Use, Change to section 4.8 - Undesirable Effects, Change to section 4.1 - Therapeutic Indications, Change to section 4.2 - Posology and Method of Administration, Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction, Change to section 4.6 - Pregnancy and Lactation

    Updated on 20 September 2005

    Reasons for updating

    • Correction of spelling/typing errors

    Updated on 16 September 2005

    Reasons for updating

    • Correction of spelling/typing errors

    Legal category:Product subject to medical prescription which may be renewed (B)

    Updated on 06 July 2005

    Reasons for updating

    • Change to section 4.1 - Therapeutic indications
    • Change to section 5.1 - Pharmacodynamic properties

    Legal category:Product subject to medical prescription which may be renewed (B)

    Updated on 04 July 2005

    Reasons for updating

    • Change to how the medicine works

    Updated on 16 September 2004

    Reasons for updating

    • New PIL for medicines.ie

    Updated on 24 March 2004

    Reasons for updating

    • Change to section 4.8 - Undesirable effects
    • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
    • Addition of joint SPC covering all presentations

    Legal category:Product subject to medical prescription which may be renewed (B)